IceCure Medical, an innovative and fast-growing medical device company and leader in the cryoablation market, is looking for a talented Regulatory Affairs Leader, to join the Quality Assurance, Regulatory Affairs and Clinical department in Caesarea, Israel.

The Regulatory Affairs Leader will report to the Regulatory Affairs Director. 

Roles and Responsibilities:

• Coordinate, review and maintain efforts associated with the preparation of regulatory documents or submissions.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Work and communicate closely with company members to assist in obtaining regulatory approvals for company’s products.
• Interpret regulatory rules or rule changes and ensure that they are communicated through policies and procedures.
• Review product promotional materials, social media and labeling for compliance with applicable regulations and policies.
• Prepare and support international submissions and international product releases (CE, FDA, etc.) in accordance with applicable SOPs.
• Prepare or maintain technical files and other regulatory documentation, as necessary, to obtain and sustain product approval.
• Write or update standard operating procedures, work instructions, or policies that support regulatory activity.
• Participate in product development, as required, to ensure the product is in compliance with regulatory requirements.

 Job Requirements:

Education and experience:

• A Bachelor’s degree in a relevant field.
• 2-3 years experience in regulatory Affairs, at a Medical Device Company
• Good communication skills both verbally and in writing
• Good analytical skills
• High ability to work independently
• Self-motivated and proactive
• Fluent in English with excellent writing skills
• Excellent computer skills, including a working knowledge of Microsoft Office applications.

The company is located in Caesarea, Israel.